Cleared Traditional

K220171 - NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220171 · Northeast Scientific, Inc. · Cardiovascular device
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Jul 2022
Decision
161d
Days
Class 2
Risk

K220171 is an FDA 510(k) clearance for the NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter. Classified as Reprocessed Atherectomy Catheter (product code QTF), Class II - Special Controls.

Submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on July 1, 2022 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K220171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2022
Decision Date July 01, 2022
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QTF Reprocessed Atherectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
Definition Reprocessed Atherectomy Device For Peripheral Vasculature. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.